510(k) · Cleared
Recalled · Class I · 2023Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Navigation, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Jun 10, 2022 as substantially equivalent to K190672 (Medtronic Navigation, Inc., 2019) after a 58-day review. Its family tree reaches back 4 generations to 2005. 4 of the 8 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 2 times, including 2 Class I recalls.
- Decided
- Jun 10, 2022
- Review
- 58 days
- Class
- Class II
- Product code
- HAW
- Recalls
- 2 (2 Class I)
- Predicates
- 1
Its longest line of descent runs back 4 generations to K050438 (2005). 5 ancestors in all, the oldest K992927 (1999). 2 later devices descend from it, 1 citing it directly. 4 of the 8 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK050438 Stealthstation System UpdateMedtronic Surgical Navigation Technologies · 2005 · Recalled
- 3 generations backK150216 Synergy CranialMedtronic Navigation, Inc. · 2015 · Recalled (Class I)
- 2 generations backK153660 StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · Recalled (Class I)
- 1 generation backK190672 StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation…Medtronic Navigation, Inc. · 2019 · Recalled (Class I)
- This deviceK221087 Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4Medtronic Navigation, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK231976 StealthStation Cranial Software, v3.1.5 (9735585)Medtronic Navigation, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK243657 ClearPoint System (Software Version 3.0)ClearPoint Neuro, Inc. · 2025
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K050438 | Stealthstation System Update | Medtronic Surgical Navigation Technologies | 2005 | 11 |
| −3 | K150216 | Synergy Cranial | Medtronic Navigation, Inc. | 2015 | Class I |
| −2 | K153660 | StealthStation System with Cranial Software | Medtronic Navigation, Inc. | 2016 | Class I |
| −1 | K190672 | StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial… | Medtronic Navigation, Inc. | 2019 | Class I |
| 0 (this device) | K221087 | Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 | Medtronic Navigation, Inc. | 2022 | — |
| +1 | K231976 | StealthStation Cranial Software, v3.1.5 (9735585) | Medtronic Navigation, Inc. | 2023 | — |
| +2 | K243657 | ClearPoint System (Software Version 3.0) | ClearPoint Neuro, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
4 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HAW device
- #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K190672 | StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1Summary page 5…IV. Classification: Class II, Stereotaxic Instrument V. Product Codes: HAW VI. Predicates: Medtronic Navigation, Inc. manufactured software; • K190672, StealthStation Synergy Cranial S7 Software v2.2.8, StealthStation Cranial Software v3.1.1 VII. Product Descripti… | 2019 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231976 | StealthStation Cranial Software, v3.1.5 (9735585) | 2023 | 1 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 11, 2023 | Class I | Z-1630-2023 | Software design | During non-axial/some axial exams, software anomalies occur during procedures affecting depth gauge graphic displays for cranial biopsy; causing displays to no longer synchronize with other navigational information showing inaccurate… |
| Apr 11, 2023 | Class I | Z-1666-2023 | Software design | In nonaxial/some axial exams if surgical plan utilized, Target Guidance selected, tip projection utilized, Navigate Projection enabled, software anomaly may occur during tumor resection/shunt placement/deep brain stimulation, where… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K190672StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1Medtronic Navigation, Inc. · 2019 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
- K153660StealthStation System with Cranial SoftwareMedtronic Navigation, Inc. · 2016 · 2 generations back · ◆ on the line of descent in FIG. 13 Class I recalls
- K150216Synergy CranialMedtronic Navigation, Inc. · 2015 · 2 generations back · ◆ on the line of descent in FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- 5 of the 5 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K231976 (Medtronic Navigation, Inc., 2023) has gone furthest, with 1 descendant of its own.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 6 | — |
What is it indicated for?
Synergy Cranial v2.2.9: The StealthStation System, with Synergy Cranial software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical procedures. The system is indicated for any medical condition in which reference to a rigid anatomical structure can be identified relative to images of the anatomy. This can include, but is not limited to, the following cranial procedures: - Cranial Biopsies -…
Read the full statement (219 words)
Synergy Cranial v2.2.9:
The StealthStation System, with Synergy Cranial software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical procedures. The system is indicated for any medical condition in which reference to a rigid anatomical structure can be identified relative to images of the anatomy. This can include, but is not limited to, the following cranial procedures:
- Cranial Biopsies
- Tumor Resections
- Craniotomies/Craniectomies
- Skull Base Procedures
- Transsphenoidal Procedures
- Thalamotomies/Pallidotomies
- Pituitary Tumor Removal
- CSF Leak Repair
- Pediatric Catheter Shunt Placement
- General Catheter Shunt Placement
StealthStation Cranial Software v3.1.4:
The StealthStation System, with StealthStation Cranial software, is intended to aid in precisely locating anatomical structures in either open or percutaneous neurosurgical procedures. The system is indicated for any medical condition in which reference to a rigid anatomical structure can be identified relative to images of the anatomy. This can include, but is not limited to, the following cranial procedures (including stereotactic frame-based and stereotactic frame alternatives-based procedures):
- Cranial biopsies (including stereotactic)
- Deep brain stimulation (DBS) lead placement
- Depth electrode placement
- Tumor resections
- Craniotomies/Craniectomies
- Skull Base Procedures
- Transsphenoidal Procedures
- Thalamotomies/Pallidotomies
- Pituitary Tumor Removal
- CSF leak repair
- Pediatric Ventricular Catheter Placement
- General Ventricular Catheter Placement
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K221087 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221087: Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221087
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026